Home NDC 70518-2695-0 Glyburide
Product NDC 70518-2695
Requested package NDC 70518-2695-0
11-digit product format 705182695
Labeler code 70518
Product ID 70518-2695_ccfc4a48-4011-ed71-e053-2995a90ac483
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glyburide
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA017532
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2020-04-16
Marketing end 0000-00-00
Substance GLYBURIDE
Active strength 3 mg/1
Pharmacologic classes Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017532-001 DIABETA GLYBURIDE 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 N017532-002 DIABETA GLYBURIDE 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 N017532-003 DIABETA GLYBURIDE 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
FDA-Initiated Inactive NDC Indexing# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Glyburide GLYBURIDE TEVA Pharmaceuticals USA Inc 50d16f1d-c814-4411-8749-62561321ecce 2021-07-01 Warnings, Adverse reactions Exact identifier application applno (NDA): 017532 application number: NDA017532
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70518-2695-0 70518269500 100 POUCH in 1 BOX (70518-2695-0) > 1 TABLET in 1 POUCH (70518-2695-1) 100 pouch 2020-04-16 0000-00-00 No No Current